The safety study’s objective was to compare the bioavailability of the current capsule formulation to two new formulations in pressed tablets. The results showed that the pressed tablets produced similar blood concentrations when compared to the capsule formulation and that the tablet formulations yielded more consistent blood levels of the active drug that is formed in the body from DB289.
The chosen formulation of DB289, the company’s first oral drug candidate, will be used in pivotal phase III studies in trypanosomiasis and pneumocystis pneumonia (PCP), as well as for commercialization.
The advantage of the pressed tablet is that it is less expensive to manufacture and more stable in conditions with high temperatures and humidity, such as those found in certain countries in sub-Sahara Africa, South America, and Asia.